Prolonged Symptoms and Reasons for Consultation in Town Medicine Associated With COVID-19 Infection in the Hauts de France Region

NCT ID: NCT04817293

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-06
• Study Completion Date: 2023-02-28

Brief Summary

Several publications document the occurrence of prolonged or late-onset symptoms beyond 3 weeks after the first clinical manifestations of SARS-COV2 infection. These manifestations may be related to thromboembolic or inflammatory events or other mechanisms that are not yet well understood. The psychosomatic origin secondary to psychiatric disorders prior to the infection or in reaction to it is also to be evoked. The identification of the clinical manifestations observed, and their clinical and paraclinical evolution are essential to better understand the natural evolution of COVID-19, to specify the physiopathological mechanisms and to identify potential avenues of management for the patients. In addition, the impact of COVID-19 infection on primary care visits is not known. In general practice, these patients benefit from explorations and even diagnoses that may explain the persistence of symptoms (autoimmune diseases, thrombosis, somatoform disorders, hyperventilation syndrome, etc.).

The objective of the COCO_Vi_LATE project is to carry out a cross-sectional study of patients presenting persistent and/or recurrent symptoms after an infection with SARS-COV-2 who will be compared to individuals with a short form of infection with COVID-19

Conditions

Covid19

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

COVID-19 positive

Questionnaire

Intervention Type: OTHER

Questionnaire SSD-12 and EQ5D5L

medical consultation

Intervention Type: OTHER

Medical consultation during the visit with data collection

COVID-19 negative

Questionnaire

Intervention Type: OTHER

Questionnaire SSD-12 and EQ5D5L

medical consultation

Intervention Type: OTHER

Medical consultation during the visit with data collection

Interventions

Questionnaire

Questionnaire SSD-12 and EQ5D5L

Intervention Type: OTHER

medical consultation

Medical consultation during the visit with data collection

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

A- For COVID cases:

1. Consultation in a city doctor's office

2. Positive SARS-CoV-2 RT-PCR result OR positive SARS-CoV-2 serology

3. Patient symptomatic or not

Definition of symptomatic :

1. Anosmia

2. OR CT scan suggestive of COVID 19

3. OR ≥ 2 symptoms contemporaneous with virologic sampling among: asthenia, cough, dyspnea, fever, myalgias, dysgeusia, diarrhea AND not present previously at diagnosis

B-. For NON COVID cases:

1. Consultation in a city doctor's office

2. No known COVID+ serology

3. No known RT- PCR SARS-CoV-2

4. No clinical suspicion of COVID-19 infection

Exclusion Criteria

1. Minor patient

2. Refusal to participate

3. Patient under protection

4. Patient requiring hospitalization for COVID-19 (excluding non-emergency hospitalization)

5. Patient consulted for the following reason only: treatment monitoring, treatment renewal or certificate, hospital discharge

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tourcoing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier ROBINEAU, MD

Role: PRINCIPAL_INVESTIGATOR

CH TOURCOING

Sophie PANAGET, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU LILLE

Locations

CH Tourcoing

Tourcoing, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Olivier ROBINEAU, MD

Role: CONTACT

orobineau@ch-tourcoing.fr

0320694949

Solange TREHOUX, PhD

Role: CONTACT

strehoux@ch-tourcoing.fr

0320694280

Other Identifiers

RIPH_2021_01

Identifier Type: -

Identifier Source: org_study_id